13 EVT801 EVT801 is the second drug in Kazia’s pipeline, but its potential to bring benefit to patients is no less than paxalisib. EVT801 works by targeting a process called angiogenesis, which is critical to the growth of many kinds of cancer. Angiogenesis denotes the formation of new blood vessels around a tumour, and this process is required to supply the tumour with nutrients and oxygen to support its rapid growth. Inhibiting angiogenesis is a very effective way to treat many such tumours, and drugs which function this way have been used across a range of cancers for several decades. There are two challenges with existing therapies in this class. First, they tend to be quite toxic due to ‘off-target’ effects on other biochemical pathways. Second, by decreasing the oxygen levels in the tumour, they trigger adaptive resistance mechanisms which mean that their effect is generally temporary. EVT801 has been designed to combat these challenges. In November 2021, EVT801 commenced recruitment to a phase I ‘first-in-human’ clinical trial. The primary purpose of any such trial is to understand the safety profile of the drug and how much can be given to patients, the ‘maximum tolerated dose’ (MTD). A phase I study also measures how long the drug remains in the body. These are key things that drug developers must understand before moving into more advanced trials. However, the EVT801 phase I study also incorporates some cuttingedge scientific measurements that will allow Kazia to better understand the likely efficacy of the drug and to assess which patients may benefit most. The trial will assess which genes are switched on and off by treatment with EVT801, how the drug affects the immune system, and whether certain features of a tumour make it more likely to respond. In addition, the trial will apply machine learning techniques to evaluate CT scans from patients, hopefully providing greater insight into their response to treatment. Kazia Theraputics Limited Annual Report 2022 EVT801 CLINICAL PROGRAM Sponsor Phase Indication Registration Kazia Therapeutics I Advanced Solid Tumours NCT05114668 20-50 patients Understand dosing and safety profile 40-200 patients Obtain initial signals of efficacy 200-2000 patients Demonstrate and quantify efficacy and safety PHASE I PHASE II PHASE III PHASES OF CANCER DRUG DEVELOPMENT 2022 at a Glance Chairman’s Letter CEO’s Report Key Milestones Pipeline Review ESG Financial Reports Our Collaborators
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